People with the genetic disorder do not make enough Factor XIII, a blood component that promotes clotting. Tretten, a human recombinant produced in yeast cells, makes up for this deficiency, which could otherwise be life threatening, the FDA said Monday in a news release.

Tretten was evaluated in a clinical study of 77 people with the disorder. Administered monthly, it was effective in preventing bleeding in 90 percent of recipients. Side effects included headache, extremity pain and pain at the injection site. No study participant developed abnormal clotting, the FDA said.

The product was developed and is produced by Novo Nordisk, based in Denmark.

More information

To learn more about this disorder, visit the National Hemophilia Foundation (http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=190&amp;contentid=58&amp;rptname=bleeding ).

-- Scott Roberts

This content is reviewed regularly and is updated when new and relevant evidence is made available. This information is neither intended nor implied to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with questions regarding a medical condition.